Measures to Improve Outcomes After an Opioid Overdose

NCT03968237 | Unknown FDA Drug

• 1 other identifier: 21455
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study that aims to develop good clinical practices to improve outcomes after an opioid overdose and transition of care from the Emergency Department (ED) into an Office Based Opioid Treatment (OBOT) clinic for patients with opioid overdose/Opioid Use Disorder (OUD). We intend to involve UVA Emergency Medicine and Medical Toxicology physicians with buprenorphine waiver or an interest in becoming waived at our institution to implement early initiation of buprenorphine protocol. We hope that this change in practice will result in better management of patients with OUD and opioid overdose, reduce relapse and improve engagement in addiction treatment. Subjects who meet criteria will be consented in the ED and receive a buprenorphine/naloxone induction protocol, prior to discharge and referral to the OBOT clinic. Subjects who consent to take part in this study will be entered in a database to track their involvement in treatment (s) at UVA and or any opioid related UVA health visits including OPIOID OVERDOSE.

Conditions

Opioid Overdose

Outcome Measures

Primary Outcomes (3)

• Clinical Opiate Withdrawal Scale (COWS)

  The COWS is an 11 item scale designed to be administered by a clinican. This tool is used to rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. Reduction in adverse events will be evaluated by the documentation of COWS scores right after administration of Naloxone, then buprenorphine/naloxone.

  at screening

• Opioid Related Emergency Department (ED) Visits

  Reduce risk of opioid re-overdose following ED buprenorphine/naloxone induction protocol. This will be measured by calculating the percentage of opioid related visits to any ED at 7 days post discharge, at 30 days post discharge, and hospital admissions at 30 days discharge.

  up to 30 days

• Treatment Engagement

  Improve addiction treatment engagement for patients receiving ED buprenorphine/naloxone induction following opioid overdose. This will be measured by the number of ED patients scheduled for follow-up at the office based opioid treatment (OBOT) clinic versus number of patients that attend the scheduled first appointment and number of patients that continue to follow-up at the OBOT clinic at 30 days and at 6 months.

  up to 6 months

Secondary Outcomes (4)

• Demographic Data

  at screening

• Brief Addiction Monitor (BAM)

  up to 6 months

• Urine Drug Screen

  up to 6 months

• HIV Risk-Taking Behavioral Scale HIV Risk-Taking Behavioral Scale

  up to 6 months

Interventions

Buprenorphine/Naloxone DRUG

Controlled substances

Also known as: Belbuca, Probuphine, Narcan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Emergency Room Department

You may qualify if:

• Age 18 years or older
• Person can read, write, and speak in English.
• Presenting to the University of Virginia ED with opioid overdose and administration of naloxone either by EMS or in the ED.
• Experiencing some withdrawal symptoms (COWS score of 12 or higher) or experiencing 3 of the following symptoms: tremor/twitching, irritability, joint or bone aches, bad chills or sweating, goose bumps
• Express an interest in receiving a buprenorphine/naloxone induction with the goal to continue the same treatment outpatient

You may not qualify if:

• Non-opioid substance overdose or overdose that does not respond to naloxone
• Patients requiring admission secondary to medical or psychiatric complications
• Patients on prescribed methadone
• Women who are pregnant; This medication may precipitate opioid withdrawal in pregnant patients with opioid use disorder. Withdrawal can harm the placenta function, preterm labor, fetal convulsions (seizures), stunted fetal growth and fetal death during pregnancy.
• Mothers who are breastfeeding
• Persons under the age of 18
• Persons not able to attend follow-up clinic visits
• Persons not able to consent
• Known allergy or sensitivity to buprenorphine

Sponsors & Collaborators

• Nassima Ait-Daoud Tiouririne: lead

Study Sites (1)

UVA Center for Leading Edge Addiction Research

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Opiate Overdose

Interventions

Buprenorphine, Naloxone Drug Combination; Buprenorphine; Naloxone

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Nassima Ait-Daoud Tiouririne, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Jenkins-Mendoza

CONTACT

(434)243-0562; emj9c@virginia.edu

Tracie Kostelac

CONTACT

(434)243-0563; tlk5d@virginia.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Director of UVA Center for Leading Edge Addiction Research

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: August 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)